Basecare-B (02170.HK) Secures NMPA Class III Approval for China’s First Fully Domestic PGT-A Sequencing Kit

Bulletin Express
Mar 16

Suzhou Basecare Medical Corporation Limited (Basecare-B, 02170.HK) has obtained a national Class III medical-device registration certificate (No. Guo Xie Zhu Zhun 20263400529) from China’s National Medical Products Administration (NMPA) for its pre-implantation genetic testing for aneuploidy (PGT-A) kit, which employs a probe-anchored polymerization sequencing method.\n\nThe kit is the first PGT-A solution in China to run entirely on a domestically developed high-throughput gene-sequencing platform, completing a localised “equipment–reagent–analysis software” chain for assisted-reproductive genetic testing. Clinical indications cover in-vitro fertilisation patients aged 35 and above, couples with chromosomal abnormalities, individuals with at least three failed embryo transfers or miscarriages, and families with prior births involving chromosomal disorders.\n\nBasecare-B reported that multi-centre validation confirmed the kit’s detection accuracy, platform compatibility and clinical applicability. By identifying chromosomal aneuploidy in embryos, the product aims to lower miscarriage risk and reduce birth-defect incidence, supporting third-generation IVF technology.\n\nManagement highlighted the milestone as the culmination of several years of R&D and a significant advance for China’s reproductive-health sector. Shareholders and prospective investors are advised to exercise caution when trading the company’s shares.

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